Dose
calculation
Selecting the
infusion schedule
Selecting the
infusion device
Preparing the
solution for infusion
Dose
administration
Calculating the individual QARZIBA® dose1
Your patient
Body weight in kilograms:
Body length in cm:
Body surface area in m2*:
Dose calculation with dead volume:
Cumulative dose per course
100 mg/m²
0.000 mg
Cumulative dose 5 courses
(complete treatment)
500 mg/m²
0.000 mg

1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf
Last accessed: March 2023. 2. Mosteller RD. N Engl J Med. 1987; 317: 1098.
Continue
Selecting the infusion schedule1
Two infusion schedules are available:
■QARZIBA® infusion
• The continuous/long-term infusion (LTI) schedule

QARZIBA® infused continuously over the first 10 days of the 35-day course. Infusion rate = 2 mL per hour. Daily dose = 10 mg/m2.

• The short-term infusion (STI) schedule

QARZIBA® infused for 8-hours per day for the first 5 days of the 35-day course. Infusion rate = 13 mL per hour. Daily infusions = 20 mg/m2.



Concomitant use of isotretinoin and IL-2 may be required. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, QARZIBA® should be combined with interleukin-2 (IL-2).1

1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf Last accessed: March 2023.
 
 
Continue
Long-term infusion schedule: Selecting the infusion device1
Short-term infusion schedule: Selecting the infusion device1
Two infusion devices are possible:

• Expert guidance recommends the first course is administered using 10x daily syringes, to assess tolerability and minimise the risk of product wastage.

• Once acceptable tolerability is confirmed, future courses can be administered using 2x 5-day infusion bags in a suitable pump.

Daily (24-hour) syringe
Total
volume:

50 mL*

4,965 mg
(1,1 ml)
Number
of vials:

1

Number of administrations
to complete 35-day course:

10

5-day (120-hour) infusion bag
Total
volume:

250 mL†

4,965 mg
(1,1 ml)
Number
of vials:

2

Number of administrations
to complete 35-day course:

2

The short-term infusion schedule requires daily preparation of the solution for infusion.


The daily dose is 20 mg/m2, and the calculated dose should be diluted in 100 mL sodium chloride 9 mg/mL (0.9%) containing 1% human albumin.


You will need to select a suitable infusion device for delivery of these volumes at an approximate infusion rate of 13 mL per hour.


Please note, this is not the SIOPEN recommended infusion schedule and should only be used in exceptional circumstances due to the increased risk of AEs.2,3
Daily patient dose (10 mg/m2):
4,965 mg
(1,1 ml)
Daily patient dose (20 mg/m2):
4,965 mg
(1,1 ml)
Total course dose:
4,965 mg
(1,1 ml)
Total treatment dose:


*Total volume infused should be 48 mL. 50 mL includes a 2 mL overfill estimate for dead volume.
†Total volume infused should be 240 mL. 250 mL includes a 10 mL overfill estimate for dead volume.

The solution for infusion can be prepared in sufficient volume for 5 days of infusion, or on a daily basis. From a microbiological view, the solution for infusion should be used immediately, if not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.1



From a microbiological view, the solution for infusion should be used immediately, if not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.1
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf
Last accessed: March 2023.
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf
Last accessed: March 2023. 2. Mueller I, et al. MABS. 2018; 10: 55–61. 3. Ladenstein R, et al. Cancers. 2020; 12: 309.
LTI
STI
 
 
 
Continue
Long-term infusion schedule: Preparing the solution for infusion1
Short-term infusion schedule: Preparing the solution for infusion1
Solution preparation depends on the volumes needed for the selected infusion device:
Daily (24-hour) syringe
5-day (120-hour) infusion bag

Total
volume:

50 mL*

*Total volume infused should be 48 mL. 50 mL includes a 2 mL overfill estimate for dead volume.

 

 

−

Human
albumin (20%):

2.5 mL†

†The final solution for infusion should contain 1% human albumin.

 

 

−

QARZIBA® solution
(4.5 mg/mL):

1

This is your patient specific daily dose

 

 

=

Sodium chloride
(9 mg/mL (0.9%)):

10

Total
volume:

250 mL*

*Total volume infused should be 240 mL. 250 mL includes a 10 mL overfill estimate for dead volume.

 

 

−

Human
albumin (20%):

12.5 mL†

†The final solution for infusion should contain 1% human albumin.

 

 

−

QARZIBA® solution
(4.5 mg/mL):

1

This is your patient specific daily dose

 

 

=

Sodium chloride
(9 mg/mL (0.9%)):

10
Daily (8-hour)
100 mL device* *Short-term infusion only. Not recommended.

Total
volume:

100 mL†

†Dead line volumes should be accounted for based on the device you are using.

 

 

−

Human
albumin (20%):

5.0 mL‡

‡The final solution for infusion should contain 1% human albumin.

 

 

−

QARZIBA® solution
(4.5 mg/mL):

1

This is your patient specific daily dose

 

 

=

Sodium chloride
(9 mg/mL (0.9%)):

10
The solution for infusion can be prepared in sufficient volume for 5 days of infusion, or on a daily basis. From a microbiological view, the solution for infusion should be used immediately, if not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.1
 
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf Last accessed: March 2023.
LTI
STI
 
 
 
Continue
Your individual administration schedule: LTI1*
Pre- and concomitant medications:
QARZIBA® 4.9 mg per day
QARZIBA® 4.9 mg over 8h/day
Antihistamine
IV injection 20 minutes prior to each QARZIBA® infusion
Every 4–6 hours, as required, during QARZIBA® infusion
Gabapentin oral*
3 days prior to QARZIBA®: 1x 300 mg
2 days prior to QARZIBA®: 2x 300 mg
1 days prior to QARZIBA®: 3x 300 mg
Opioids*
Morphin IV before QARZIBA® infusion:
Bolus (0,204 - 0,510 mg/hour) 2 hours before
 
During QARZIBA® infusion:
Continue with 0,306 mg/h
 
With continuous infusion, in response to the patient’s pain perception, it may be possible to wean off morphine over 5 days by progressively decreasing its dosing rate (e.g., to 0.02 mg/kg/hour, 0.01 mg/kg/hour, 0.005 mg/kg/hour)


After weaning off intravenous morphine, in case of severe neuropathic pain, oral morphine sulphate (0.2 to 0.4 mg/kg every 4 to 6 hours) can be administered on demand. For moderate neuropathic pain, oral tramodol may be administered.
With daily infusions of QARZIBA®, morphine infusion should be continued at a decreased rate (e.g. 0.01 mg/kg/h) for 4 hours after the end of the infusion.


After weaning off intravenous morphine, in case of severe neuropathic pain, oral morphine sulphate (0.2 to 0.4 mg/kg every 4 to 6 hours) can be administered on demand. For moderate neuropathic pain, oral tramodol may be administered.
Non-opioid analgesics
e.g., paracetamol and ibuprofen
 
Permanently during QARZIBA® infusion
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf Last accessed: March 2023. Administration of interleukin-2 if indicated.
IV, intravenous; LTI, long-term infusion.
*Your patient specific dose
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf Last accessed: March 2023. Administration of interleukin-2 if indicated.
IV, intravenous; STI, short-term infusion.
*Your patient specific dose


The following schedule is specific to each patient. It is based on the patient data you entered at the beginning.
The following schedule is specific to each patient. It is based on the patient data you entered at the beginning.
Gabapentin oral

1x 102 mg/day, 2x 102 mg/day, 3x 102 mg/day

Maximum single dose is 300 mg. Dosing schedule should be maintained for as long as required.
Tapering off after weaning off IV morphine infusion, at the latest after QARZIBA® infusion has stopped.

Morphine IV administration

Morphine as bolus infusion of 0.02 to 0.05 mg/kg/hour morphine 2 hours before continuous QARZIBA® infusion.

Subsequently, a dosing rate of 0.03 mg/kg/hour is recommended concomitantly with QARZIBA® infusion. If necessary, weaning off by the hour depending on the pain intensity.

On-demand opioid medication (after weaning off intravenous morphine)

  • Severe neuropathic pain: oral morphine sulphate (0.2 to 0.4 mg/kg every 4–6 hours)
  • Moderate neuropathic pain: oral tramadol
Non-opioid analgesics

Non-opioid analgesics should be used permanently during QARZIBA® infusion, e.g., paracetamol or ibuprofen.

LTI
STI
 
Download
Dose
calculation
Selecting the
infusion schedule
Selecting the
infusion device
Preparing the
solution for infusion
Dose
administration
Calculating the individual QARZIBA® dose1
Your patient
Body weight in kilograms:
Body length in cm:
Body surface area in m2*:
Dose calculation with dead volume:
Cumulative dose per course
100 mg/m²
0.000 mg
Cumulative dose 5 courses
(complete treatment)
500 mg/m²
0.000 mg
Continue

 
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf
Last accessed: March 2023. 2. Mosteller RD. N Engl J Med. 1987; 317: 1098.
Selecting the infusion schedule1
Two infusion schedules are available:

• The continuous/long-term infusion (LTI) schedule
■QARZIBA® infusion

QARZIBA® infused continuously over the first 10 days of the 35-day course. Infusion rate = 2 mL per hour. Daily dose = 10 mg/m2.

• The short-term infusion (STI) schedule

QARZIBA® infused for 8-hours per day for the first 5 days of the 35-day course. Infusion rate = 13 mL per hour. Daily infusions = 20 mg/m2.

Continue

Concomitant use of isotretinoin and IL-2 may be required. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, QARZIBA® should be combined with interleukin-2 (IL-2).1



1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf Last accessed: March 2023.
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf Last accessed: March 2023. 2. Mueller I, et al. MABS. 2018; 10: 55–61. 3. Ladenstein R, et al. Cancers. 2020; 12: 309.
Long-term infusion schedule: Selecting the infusion device1
Short-term infusion schedule: Selecting the infusion device1
Two infusion devices are possible:
• Expert guidance recommends the first course is administered using 10x daily syringes, to assess tolerability and minimise the risk of product wastage.
• Once acceptable tolerability is confirmed, future courses can be administered using 2x 5-day infusion bags in a suitable pump.

Daily (24-hour) syringe
Total
volume:

50 mL*

4,965 mg
(1,1 ml)
Number
of vials:

1

Number of administrations to complete 35-day course:

10

5-day (120-hour) infusion bag
Total
volume:

250 mL†

4,965 mg
(1,1 ml)
Number
of vials:

2

Number of administrations to complete 35-day course:

2

The short-term infusion schedule requires daily preparation of the solution for infusion.


The daily dose is 20 mg/m2, and the calculated dose should be diluted in 100 mL sodium chloride 9 mg/mL (0.9%) containing 1% human albumin.


You will need to select a suitable infusion device for delivery of these volumes at an approximate infusion rate of 13 mL per hour.


Please note, this is not the SIOPEN recommended infusion schedule and should only be used in exceptional circumstances due to the increased risk of AEs.2,3
Daily patient dose (10 mg/m2):
4,965 mg
(1,1 ml)
Daily patient dose (20 mg/m2):
4,965 mg
(1,1 ml)
Total course dose:
4,965 mg
(1,1 ml)
Total treatment dose:

*Total volume infused should be 48 mL. 50 mL includes a 2 mL overfill estimate for dead volume.

The solution for infusion can be prepared in sufficient volume for 5 days of infusion, or on a daily basis. From a microbiological view, the solution for infusion should be used immediately, if not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.1
From a microbiological view, the solution for infusion should be used immediately, if not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.1
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf
Last accessed: March 2023.
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at:
https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf
Last accessed: March 2023. 2. Mueller I, et al. MABS. 2018; 10: 55–61. 3. Ladenstein R, et al. Cancers. 2020; 12: 309.
LTI
STI
 
 
 
Continue
Long-term infusion schedule: Preparing the solution for infusion1
Short-term infusion schedule: Preparing the solution for infusion1
Solution preparation depends on the volumes needed for the selected infusion device:
Daily (24-hour) syringe
5-day (120-hour) infusion bag

Total
volume:

50 mL*

*Total volume infused should be 48 mL. 50 mL includes a 2 mL overfill estimate for dead volume.

 

 

−

Human
albumin (20%):

2.5 mL†

†The final solution for infusion should contain 1% human albumin.

 

 

−

QARZIBA® solution
(4.5 mg/mL):

1

This is your patient specific daily dose

 

 

=

Sodium chloride
(9 mg/mL (0.9%)):

10
Daily (8-hour) 100 mL device* *Short-term infusion only. Not recommended.

Total
volume:

100 mL*

†Dead line volumes should be accounted for based on the device you are using.

 

 

−

Human
albumin (20%):

5.0 mL†

†The final solution for infusion should contain 1% human albumin.

 

 

−

QARZIBA® solution
(4.5 mg/mL):

1

This is your patient specific daily dose

 

 

=

Sodium chloride
(9 mg/mL (0.9%)):

10
The solution for infusion can be prepared in sufficient volume for 5 days of infusion, or on a daily basis. From a microbiological view, the solution for infusion should be used immediately, if not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8ºC, unless dilution has taken place in controlled and validated aseptic conditions.1
 
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf Last accessed: March 2023.
LTI
STI
 
 
 
Continue
Your individual administration schedule: LTI1*
Pre- and concomitant medications:
QARZIBA® 4.9 mg per day
QARZIBA® 4.9 mg over 8h/day
Antihistamine
IV injection 20 minutes prior to each QARZIBA® infusion
Every 4–6 hours, as required, during QARZIBA® infusion
Gabapentin oral*
3 days prior to QARZIBA®: 1x 300 mg
2 days prior to QARZIBA®: 2x 300 mg
1 days prior to QARZIBA®: 3x 300 mg
Opioids*
Morphin IV before QARZIBA® infusion:
Bolus (0,204 - 0,510 mg/hour) 2 hours before
 
During QARZIBA® infusion:
Continue with 0,306 mg/h
 
With continuous infusion, in response to the patient’s pain perception, it may be possible to wean off morphine over 5 days by progressively decreasing its dosing rate (e.g., to 0.02 mg/kg/hour, 0.01 mg/kg/hour, 0.005 mg/kg/hour)


After weaning off intravenous morphine, in case of severe neuropathic pain, oral morphine sulphate (0.2 to 0.4 mg/kg every 4 to 6 hours) can be administered on demand. For moderate neuropathic pain, oral tramodol may be administered.
With daily infusions of QARZIBA®, morphine infusion should be continued at a decreased rate (e.g. 0.01 mg/kg/h) for 4 hours after the end of the infusion.


After weaning off intravenous morphine, in case of severe neuropathic pain, oral morphine sulphate (0.2 to 0.4 mg/kg every 4 to 6 hours) can be administered on demand. For moderate neuropathic pain, oral tramodol may be administered.
Non-opioid analgesics
e.g., paracetamol and ibuprofen
 
Permanently during QARZIBA® infusion
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf Last accessed: March 2023. Administration of interleukin-2 if indicated.
IV, intravenous; LTI, long-term infusion.
*Your patient specific dose
1. QARZIBA® (dinutuximab beta). Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/qarziba-epar-product-information_en.pdf Last accessed: March 2023. Administration of interleukin-2 if indicated.
IV, intravenous; STI, short-term infusion.
*Your patient specific dose


The following schedule is specific to each patient. It is based on the patient data you entered at the beginning.
The following schedule is specific to each patient. It is based on the patient data you entered at the beginning.
Gabapentin oral

1x 102 mg/day, 2x 102 mg/day, 3x 102 mg/day

Maximum single dose is 300 mg. Dosing schedule should be maintained for as long as required.
Tapering off after weaning off IV morphine infusion, at the latest after QARZIBA® infusion has stopped.

Morphine IV administration

Morphine as bolus infusion of 0.02 to 0.05 mg/kg/hour morphine 2 hours before continuous QARZIBA® infusion.

Subsequently, a dosing rate of 0.03 mg/kg/hour is recommended concomitantly with QARZIBA® infusion. If necessary, weaning off by the hour depending on the pain intensity.

On-demand opioid medication (after weaning off intravenous morphine)

  • Severe neuropathic pain: oral morphine sulphate (0.2 to 0.4 mg/kg every 4–6 hours)
  • Moderate neuropathic pain: oral tramadol
Non-opioid analgesics

Non-opioid analgesics should be used permanently during QARZIBA® infusion, e.g., paracetamol or ibuprofen.

LTI
STI
 
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ABBREVIATED PRESCRIBING INFORMATION – QARZIBA (dinutuximab beta).

Before prescribing Qarziba please refer to full Summary of Product Characteristics.

Presentation: Concentrate for solution for infusion containing 20 mg dinutuximab beta. Indication: For the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin 2 (IL-2). Dosage & Administration: Restricted to hospital-use only and must be administered under the supervision of a physician experienced in the use of oncological therapies. It must be administered by a healthcare professional prepared to manage severe allergic reactions including anaphylaxis in an environment where full resuscitation services are immediately available. Treatment consists of 5 consecutive courses, each course comprising 35 days. The individual dose is determined based on the body surface area and should be a total of 100 mg/m2 per course. Two modes of administration are possible: 1) continuous infusion over the first 10 days of each course (a total of 240 hours) at the daily dose of 10 mg/m2 or 2) five daily infusions of 20 mg/m2 administered over 8 hours, on the first 5 days of each course. When IL-2 is combined with Qarziba, it should be administered as subcutaneous injections of 6×106 IU/m2/day, for 2 periods of 5 consecutive days, resulting in an overall dose of 60×106 IU/m2 per course. The first 5 day course should start 7 days prior to the first infusion of Qarziba and the second 5 day course should start concurrently with Qarziba infusion (days 1 to 5 of each Qarziba course). Paediatric population: The safety and efficacy of Qarziba in children aged less than 12 months have not yet been established. No data are available. Renal impairment: No data are available. Hepatic impairment: No data are available. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Acute grade 3 or 4, or extensive chronic graft-versus-host disease (GvHD). Special warnings and precautions for use: Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Pain: Neuropathic pain usually occurs at the beginning of the treatment and premedication with analgesics, including intravenous opioids, prior to each infusion of Qarziba is required. A triple therapy, including nonopioid analgesics (according to WHO guidelines), gabapentin and opioids, is recommended for pain treatment. The individual dose may vary widely. Hypersensitivity reactions: Severe infusion-related reactions, including cytokine release syndrome (CRS), anaphylactic and hypersensitivity reactions, may occur despite the use of premedication. Occurrence of a severe infusion related reaction (including CRS) requires immediate discontinuation of Qarziba therapy and may necessitate emergency treatment. CRS frequently manifests itself within minutes to hours of initiating the first infusion and is characterised by systemic symptoms such as fever, hypotension and urticaria. Anaphylactic reactions may occur as early as within a few minutes of the first infusion with Qarziba and are commonly associated with bronchospasm and urticaria. Capillary leak syndrome (CLS): Usually develops within hours after initiation of treatment, while clinical symptoms (i.e. hypotension, tachycardia) are reported to occur after 2 to 12 hours. Careful monitoring of circulatory and respiratory function is required. Neurological disorders of the eye: May occur as Qarziba binds to optic nerve cells. No dose modification is necessary in the case of an impaired visual accommodation that is correctable with eye glasses, as long as this is judged to be tolerable. Treatment must be interrupted in patients who experience Grade 3 vision toxicity. In case of any eye problems, patients should be referred promptly to an ophthalmology specialist. Peripheral neuropathy: Occasional occurrences of peripheral neuropathy have been reported. Cases of motor or sensory neuropathy lasting more than 4 days must be evaluated and non-inflammatory causes, such as disease progression, infections, metabolic syndromes and concomitant medication, should be excluded. Treatment should be permanently discontinued in patients experiencing any objective prolonged weakness attributable to Qarziba administration. For patients with moderate (Grade 2) neuropathy (motor with or without sensory), treatment should be interrupted and may be resumed after neurologic symptoms resolve. Central neurotoxicity: Central neurotoxicity has been reported following treatment with Qarziba. If central neurotoxicity occurs the infusion should be interrupted immediately and the patient treated symptomatically, other influencing factors such as active infection, metastatic spread of neuroblastoma to central nervous system, neurotoxic concomitant medications should be ruled out. Treatment with Qarziba should be permanently discontinued following the occurrence of severe neurotoxicity that includes Grade 3 or 4 central neurotoxicity with substantial prolonged neurological deficit without any detectable reason, recurrent grade 1-3 neurotoxicity and/or permanent neurological deficit and all grades of posterior reversible encephalopathy syndrome and transverse myelitis. Systemic infections: Patients are likely to be immunocompromised as a result of prior therapies as they typically have a central venous catheter in situ, they are at risk of developing systemic infection. Patients should have no evidence of systemic infection and any identified infection should be under control before starting therapy. Haematologic toxicities: Occurrence has been reported with Qarziba, such as erythropenia, thrombocytopenia or neutropenia. Grade 4 haematologic toxicities, improving to at least Grade 2 or baseline values by start of next treatment course, do not require dose modification. Laboratory abnormalities: Regular monitoring of liver function and electrolytes is recommended. Interactions: No studies performed. A risk for indirect reduction of CYP activity due to higher TNF-α and IL-6 levels and, therefore, interactions with concomitantly used medicinal products, cannot be excluded. Corticosteroids: Due to their immunosuppressive activity, concomitant treatment with corticosteroids is not recommended within 2 weeks prior to the first treatment course until 1 week after the last treatment course with Qarziba, except for life-threatening conditions. Vaccinations: Should be avoided during administration of Qarziba until 10 weeks after the last treatment course, due to immune stimulation through Qarziba and possible risk for rare neurological toxicities. Intravenous immunoglobulin: Concomitant use of intravenous immunoglobulins is not recommended as they may interfere with Qarziba-dependent cellular cytotoxicity. Women of childbearing potential/contraception in males and females: Qarziba should not be used in women of childbearing potential not using contraception. It is recommended that women of childbearing potential use contraception for 6 months after discontinuation of treatment with Qarziba. Pregnancy: Qarziba should not be used during pregnancy. Breast feeding – No data. Breast-feeding should be discontinued during treatment and for 6 months after the last dose. Fertility - Unknown. Effects on ability to drive and use machines: Qarziba has major influence on the ability to drive and use machines. Patients should not use or drive machines during treatment with Qarziba. Side effects: Very common (≥ 1/10) - infection (including pneumonia, skin infection, herpes virus infection, myelitis, encephalomyelitis), device related infection, anaemia, leukopenia, neutropenia, thrombocytopenia, hypersensitivity, cytokine release syndrome, fluid retention, headache, mydriasis, pupillotonia, eye oedema (eyelid, periorbital), tachycardia, hypotension, capillary leak syndrome, hypoxia, cough, vomiting, diarrhoea, constipation, stomatitis, pruritus, rash, urticaria, pyrexia, chills, pain (includes abdominal pain, pain in extremity, oropharyngeal pain, and back pain reported in >10% of patients. In addition, other common pain types reported were arthralgia, injection site pain, musculoskeletal pain, bone pain, chest pain, and neck pain), peripheral oedema, face oedema, increased weight, increased transaminases, increased gamma glutamyltransferase, increased blood bilirubin increased blood creatinine. Common (≥ 1/100 to < 1/10) – sepsis, lymphopenia, anaphylactic reaction, decreased appetite, hypoalbuminaemia, hyponatraemia, hypokalaemia, hypophosphataemia, hypomagnesaemia, hypocalcaemia, dehydration, agitation, anxiety, peripheral neuropathy, seizure, paraesthesia, dizziness, tremor, ophthalmoplegia, papilloedema, accommodation disorder, blurred vision, photophobia, cardiac failure, left ventricular dysfunction, pericardial effusion, hypertension, bronchospasm, dyspnoea, respiratory failure, lung infiltration, pulmonary oedema, pleural effusion, tachypnoea, laryngospasm, nausea, lip oedema, ascites, abdominal distension, ileus, dry lips, dermatitis (including exfoliative), erythema, dry skin, hyperhidrosis, petechiae, photosensitivity reaction, muscle spasms, oliguria, urinary retention, hyperphosphaturia, haematuria, proteinuria, injection site reaction, decreased weight, decreased glomerular filtration rate, hypertriglyceridaemia, prolonged activated partial thromboplastin time, prolonged prothrombin time, prolonged thrombin time. Uncommon (≥ 1/1,000 to < 1/100) - disseminated intravascular coagulation, eosinophilia, serum sickness, intracranial pressure increased, posterior reversible encephalopathy syndrome, hypovolaemic shock, veno-occlusive disease, enterocolitis, hepatocellular injury, renal failure. Packaging, quantity and price: Glass vial containing 4.5 ml concentrate for solution for infusion. The pricing of Qarziba and associated reimbursement differs between countries. Please check with your local country for specific details. Storage requirements: Unopened vial - 4-year shelf-life. Store in a refrigerator (2°C – 8°C). Keep the vial in the outer carton in order to protect from light. In-use stability - demonstrated for up to 48 hours at 25°C (50 ml syringe) and for up to 7 days at 37°C (250 ml infusion bag), after cumulative storage in a refrigerator (2°C – 8°C) for 72 hours. From a microbiological point of view, the product should be used immediately. Legal Category: POM. Marketing Authorisation Number: EU/1/17/1191/001. Full prescribing information, including the SmPC, is available from the Marketing Authorisation Holder: EUSA Pharma (Netherlands) B.V., Beechavenue 54, 1119PW, Schiphol-Rijk, Netherlands Date of preparation: February 2023 – GL-DNB-2300005

Adverse events should be reported as per local regulatory authority requirements.
Adverse events should also be reported to
E: safety@eusapharma.com

Installing the APP
You can now download this guide as an app, and use it offline (without having to be connected to the internet).
You will only need to be connected to the internet to download the app.
1. Open the guide on your browser and select ’Add to start screen‘ - please see further instructions below
2. Start the app by selecting the home screen icon
3. All content will be downloaded to the device of your choice
4. When the download is complete, you will be able to use the app offline (without having to be connected to the internet)
Instructions on step 1. Please choose the operating system of your device:
iOS - Safari
Tap the 'Share' button on the website's Safari screen

Then tap the 'Install App' button.

Tap the 'Add' button at the top right.

Start the APP by tapping the symbol on the home screen.

Android
Tap the 'Menu' button in the browser.

Then, tap the 'Add to Home Screen' button.

Confirm the dialog with 'Install'.

Start the APP by tapping the symbol on the home screen.

Legal Notice

This web application is for guidance only, and should not be used as an absolute basis for making decisions about treatment or treatment combinations with concomitant medications. It is of crucial importance to examine the appropriate course of treatment on a case-by-case basis. The attending physician must take into account the individual circumstances of the patient.

In addition, every healthcare professional dealing with QARZIBA® (Dinutuximab beta) is obliged to check the correctness of the information on their own responsibility before prescribing and using the medication, in particular using the latest SmPCs from the manufacturer. It cannot be guaranteed that the information in this guide is absolutely correct.

EUSA Pharma (UK) Limited
Breakspear Park, Breakspear Way
HP2 4TZ Hemel Hempstead
+44 (0)330 500 1140
medicalinformation-uk@eusapharma.com
www.eusapharma.com